We have a current opportunity for a Clinical Development Director on a permanent basis. The position will be based in Rockville, MD (work from home flexibility). For further information about this position please apply.
Summary: A cutting-edge biopharmaceutical company is seeking a Clinical Development Director to join their thriving team. This company is a pioneer in the development of novel medicines using antibody-based technology and have an urgent need for a qualified and motivated candidate!
The Clinical Development Director will be responsible for…
- Medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications.
- Collaborating with colleagues in clinical development and operations, research, biopharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
- Ensuring that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company's sponsored clinical trials.
- Interacting closely with the pre-clinical team to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
- Providing medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
Education & Credentials
- D., or D.O. with subspecialty and board eligibility/certification in oncology
- Significant experience in Oncology drug development may substitute for oncology specialization
- Minimum of 3 years of successful clinical research and/or drug development experience in biologics
- Possesses early phase clinical development experience
- Clinical development experience in the pharmaceutical/biotechnology industry or academic medical setting
- This organization offers a competitive salary, bonus structure and stock options
- Medical Dental and Vision
If you are interested in the Director of Clinical Development role please don't wait to apply!